Correlation of Toxins With Gastrointestinal (GI) and Overall Health

Vibrant

Status: Not yet enrolling

Conditions: Gastrointestinal Diseases

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT06278311

20235761

Details and patient eligibility

About

The goal of this observational study is to evaluate the levels of urinary environmental toxins, heavy metals, PFAS and mycotoxins with gastrointestinal (GI) and overall health.

Full description

This study aims to use urine samples to understand the effect of toxins such as environmental toxins, heavy metals, PFAS and mycotoxins on GI and overall health. Urine samples will be tested using mass-spectroscopy-based techniques. A 'total toxicity score' will be calculated based on the urine analysis of toxins. A 'symptoms score' will be determined using the 'Symptom History' form which will be used to assess the patient's GI conditions. Additionally, a 'diagnosis score' will be calculated from the diagnosis generated in the electronic medical record (EMR). The determined 'total toxicity score' will be correlated with the 'symptoms score' and the 'diagnosis score.' The observations from this study will help us understand the potential effect of environmental toxins, heavy metals, PFAS and mycotoxins on GI and overall health.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients suffering from gastrointestinal and/or other symptoms
• Patients willing to provide urine samples
• Patients willing to provide consent

Exclusion criteria

• Use of antibiotics 2 weeks prior to the study
• Patients unwilling to consent

Trial design

250 participants in 2 patient groups

Patients

Description:

This group will include individuals presenting with digestive and/or non-digestive symptoms or conditions and whose medical evaluation necessitates 'toxin assessment.'

Healthy controls

Description:

This group will include individuals not presenting with digestive and/or non-digestive symptoms or conditions and who volunteer to provide urine samples for 'toxin assessment.'